FEMSEVEN CONTI 50 MICROGRAMS/7 MICROGRAMS/24 HOURS TRANSDERMAL PATCH

Transcript

Package Leaﬂet: information for the user

FemSeven® Conti
50 micrograms/7 micrograms/24 hours, transdermal patch
estradiol hemihydrate/levonorgetrel
Read all of this leaﬂet carefully before you start using this medicine because it contains important
information for you.
• Keep this leaﬂet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaﬂet. See section 4.
What is in this leaﬂet:
1. What FemSeven® Conti is and what it is used for
2. What you need to know before you use
FemSeven® Conti
3. How to use FemSeven® Conti
4. Possible side effects
5. How to store FemSeven® Conti
6. Contents of the pack and other information

1. WHAT FEMSEVEN® CONTI IS AND
WHAT IT IS USED FOR
FemSeven® Conti is a Hormone Replacement Therapy
(HRT). It contains two types of female hormones, an
oestrogen (Estradiol hemihydrate) and a progestogen
(levonorgestrel). FemSeven® Conti is used in
postmenopausal women more than one year after
menopause.
FemSeven® Conti is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen
produced by a woman’s body drops. This can cause
symptoms such as hot face, neck and chest
(“hot ﬂushes”). FemSeven® Conti alleviates these
symptoms after menopause. You will only be
prescribed FemSeven® Conti if your symptoms
seriously hinder your daily life.
Experience of treating women older than 65 years is
limited.

2. WHAT YOU NEED TO KNOW BEFORE
YOU USE FEMSEVEN CONTI®
Medical history and regular check-ups

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The use of HRT carries risks which need to be
considered when deciding whether to start taking it,
or whether to carry on taking it.
The experience treating women with a premature
menopause (due to ovarian failure or surgery) is limited.
If you have a premature menopause the risk of using
HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask
about your own and your family’s medical history.
Your doctor may decide to perform a physical
examination. This may include an examination of your
breasts and/or an internal examination, if necessary.
Once you have started on FemSeven® Conti you
should see your doctor for regular check-ups
(at least once a year). At these check-ups, discuss
with your doctor the beneﬁts and risks of continuing
with FemSeven® Conti.
Go for regular breast screening, as recommended by
your doctor.
Do not use FemSeven® Conti:
If any of the following applies to you. If you are not
sure about any of the points below, talk to your
doctor before using FemSeven® Conti.
Do not use FemSeven® Conti
• If you have or have ever had breast cancer, or if
you are suspected of having it.
• If you have cancer which is sensitive to
oestrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it.
• If you have any unexplained vaginal bleeding.
• If you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not being
treated.
• If you have or have ever had a blood clot in a
vein (thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism).
• If you have a blood clotting disorder (such as
protein C, protein S, or antithrombin deﬁciency).
• If you have or recently have had a disease caused
by blood clots in the arteries, such as a heart
attack, stroke or angina.
• If you have or have ever had a liver disease and
your liver function tests have not returned to normal.
• If you have a rare blood problem called “porphyria”
which is passed down in families (inherited).
• If you are allergic (hypersensitive) to estradiol
hemihydrate and/or levonorgestrel or any of the
other ingredients of FemSeven® Conti
(listed in section 6)
If any of the above conditions appear for the ﬁrst
time while using FemSeven® Conti, stop using it at
once and consult your doctor immediately.

Tell your doctor if you have ever had any of the
following problems, before you start the treatment,
as these may return or become worse during
treatment with FemSeven® Conti. If so, you should
see your doctor more often for check-ups:
• ﬁbroids inside your womb;
• growth of womb lining outside your womb
(endometriosis) or a history of abnormal growth of
the womb lining (endometrial hyperplasia);
• increased risk of developing blood clots (see “Blood
clots in a vein (thrombosis)”);
• increased risk of getting an oestrogen-sensitive
cancer (such as having a mother, sister or
grandmother who has had breast cancer);
• high blood pressure;
• a liver disorder, such as a benign liver tumour;
• diabetes;
• gallstones;
• migraine or severe headaches;
• a disease of the immune system that affects many
organs of the body (systemic lupus erythematosus,
SLE);
• epilepsy;
• asthma;
• a disease affecting the eardrum and hearing
(otosclerosis);
• a very high level of fat in your blood (triglycerides);
• ﬂuid retention due to cardiac or kidney problems.
Stop using FemSeven® Conti and see a doctor
immediately:
If you notice any of the following when using HRT:
• any of the conditions mentioned in the “Do not
use FemSeven® Conti” section;
• yellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease;
• a large rise in your blood pressure (symptoms may
be headache, tiredness, dizziness);
• migraine-like headaches which happen for the
ﬁrst time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs;
• sudden chest pain;
• difﬁculty breathing.
For more information, see “Blood clots in a vein
(thrombosis)”
Note: FemSeven® Conti is not a contraceptive. If it is
less than 12 months since your last menstrual period
or you are under 50 years old, you may need to use
additional contraception to prevent pregnancy.
Speak to your doctor for advice.’

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

FemSeven® Conti and cancer
Excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the
lining of the womb (endometrial cancer).
Taking oestrogen-only HRT will increase the risk of
excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the womb
lining (endometrial cancer).
The progestogen in FemSeven® Conti protects you
from this extra risk.
In women who still have a womb and who are not
taking HRT, on average, 5 in 1 000 will be diagnosed
with endometrial cancer between the ages of
50 and 65.
For women aged 50 to 65 who still have a womb and
who take oestrogen-only HRT, between 10 and 60
women in 1 000 will be diagnosed with endometrial
cancer (i.e. between 5 and 55 extra cases), depending
on the dose and for how long it is taken.
Irregular bleeding
You may have irregular bleeding or drops of blood
(spotting) during the ﬁrst 3-6 months of taking
FemSeven® Conti.
However, if the irregular bleeding:
• carries on for more than the ﬁrst 6 months;
• starts after you have been taking FemSeven® Conti
for more than 6 months;
• carries on after you have stopped taking
FemSeven® Conti.
see your doctor as soon as possible
Breast cancer:
Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional
risk becomes clear within a few years. However, it
returns to normal within a few years (at most ﬁve)
after stopping treatment.
Compare
Women aged 50 to 79 who are not taking HRT, on
average, 9 to 14 in 1 000 will be diagnosed with
breast cancer over a 5-year period. For women aged
50 to 79 who are taking oestrogen progestogen HRT
over 5 years, there will be 13 to 20 cases in 1 000
users (i.e. an extra 4 to 6 cases)
Regularly check your breasts. See your doctor if
you notice any changes such as:
• dimpling of the skin;
• changes in the nipple;
• any lumps you can see or feel.
Additionally you should attend your mammography
appointment when you are invited for screening
between your 50th and 53rd birthday, although in
some areas you’ll be invited from the age of 47 as
part of the trial extension of the programme.
For the mammogram appointment it is important
that you inform the nurse or doctor who is actually
taking the X ray that you are on HRT as this
medication may increase the density of your breast
which will affect the outcome of the mammogram.
Where the density of the breast is increased the
mammogram may not detect all lumps.
Ovarian cancer:
Ovarian cancer is rare– much rarer than breast
cancer.
The use of oestrogen-only or combined oestrogenprogestagen HRT has been associated with a slightly
increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example
in women aged 50 to 54 who are not taking HRT,
about 2 women in 2000 will be diagnosed with
ovarian cancer over a 5-year period. For women who
have been taking HRT for 5 years, there will be about
3 cases per 2000 users (i.e. about 1 extra case)

Effect of FemSeven® Conti on heart and
circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to
3- times higher in HRT users than in nonusers,
especially during the ﬁrst year of taking it.
Blood clots can be serious, and if one travels to the
lungs, it can cause chest pain, breathlessness,
fainting or even death.
You are more likely to get a blood clot in your veins
as you get older and if any of the following applies
to you. Inform your doctor if any of these situations
applies to you:
• you are unable to walk for a long time because of
major surgery, injury or illness (see also section 3,
if you need to have surgery);
• you are seriously overweight (BMI>30 kg/m2);
• you have any blood clotting problem that needs
long-term treatment with a medicine used to
prevent blood clots;
• if any of your close relatives has ever had a blood
clot in the leg, lung or another organ;
• you have systemic lupus erythematosus (SLE);
• you have cancer.
For signs of a blood clot, see “Stop using FemSeven®
Conti and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT,
on average, over a 5-year period, 4 to 7 in 1000 would
be expected to get a blood clot in a vein.
For women in their 50s who have been taking
oestrogen-progestogen HRT for over 5 years, there will
be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
attack.
Women over the age of 60 years who use oestrogenprogestogen HRT are slightly more likely to develop
heart disease than those not taking any HRT.
Stroke
The risk of getting stroke is about 1.5-times higher in
HRT users than in non-users. The number of extra cases
of stroke due to use of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking
HRT, on average, 8 in 1 000 would be expected to
have a stroke over a 5-year period. For women in
their 50s who are taking HRT, there will be 11 cases
in 1 000 users, over 5 years (i.e. an extra 3 cases).
Other conditions
• HRT will not prevent memory loss. There is some
evidence of a higher risk of memory loss in women
who start using HRT after the age of 65.
Speak to your Doctor for advice.

Other medicines and FemSeven® Conti
Some medicines may interfere with the effect of
FemSeven® Conti. This might lead to irregular
bleeding. This applies to the following medicines:
• Medicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepin);
• Medicines for tuberculosis (such as rifampicin,
rifabutin);
• Medicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelﬁnavir);
• Herbal remedies containing St John’s Wort
(Hypericum perforatum).
Tell your doctor or pharmacist if you are taking, have
recently taken or Version
might take
other medicines.
REG0089037
4.3 anyApproved

Valid For 7 Days from

Page 1 of 3

14-Mar-2016

120mm

Laboratory tests

If you stop using FemSeven® Conti

If you need a blood test, tell your doctor or the
laboratory staff that you are using FemSeven® Conti,
because this medicine can affect the results of some
tests.

The premenopausal signs linked to a lack of oestrogen
(such as hot face, neck and chest) may reappear.

If you need to have surgery
If you are going to have surgery, tell the surgeon that
you are using FemSeven® Conti. You may need to stop
using FemSeven® Conti about 4 to 6 weeks before the
operation to reduce the risk of a blood clot
(see section 2, Blood clots in vein). Ask your doctor
when you can start taking FemSeven Conti® again.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Pregnancy and breast-feeding
FemSeven® Conti is for use in postmenopausal
women only. If you become pregnant, stop using
FemSeven® Conti and contact your doctor.

3. HOW TO USE FEMSEVEN® CONTI
Dosage
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
• FemSeven® Conti has to be applied once a week,
i.e. each patch is replaced every 7 days. FemSeven®
Conti is a continuous combined hormone
replacement therapy (HRT) treatment without a
treatment-off phase: as one patch is removed, the
next is applied immediately. Forgetting to change a
patch on schedule may increase the likelihood of
break-through bleeding or spotting.
• If you are not taking HRT or you are transferring
from another continuous combined HRT product,
treatment with FemSeven® Conti may be started
on any convenient day.
• If you are transferring from sequential HRT
regimens, treatment should start right after your
withdrawal bleeding has ended.
Your doctor will aim to prescribe the lowest dose to
treat your symptoms for as short a time as
necessary. Speak to your doctor if you think this
dose is too strong or not strong enough.

Method of administration
• FemSeven® Conti should be applied on your skin
(transdermal use). Wash and clean the area
thoroughly and dry the skin before application, if
possible apply to skin that is free from hair.
• FemSeven® Conti should be applied to clean, dry,
healthy skin (which is neither irritated nor grazed)
Do not apply to skin that has been recently treated
with cosmetic creams or sun protection products.
Avoid using bath oils in your bath or shower gels
containing moisturising or oily ingredients, as this
may affect patch adhesion anywhere on the body.
• FemSeven® Conti should be applied to an area of
skin without major skin folds, i.e. the buttocks or
hips, and not subject to chaﬁng by clothing (avoid
the waist and avoid wearing tight clothing that
could loosen the transdermal patch). Do not try to
check if it has stuck by attempting to lift the edge
as this may make it come loose.
• Wait at least one hour after patch application
before you try any strenuous activity or exercise
that will make you perspire (sweat) a lot as this
can affect patch adhesion.
• Also, wait an hour after patch application before
wet activity. This includes bathing, showering,
swimming or use of a steam room.
Other factors that may cause poor adhesion are:
• Excessive perspiration, hot ﬂushes, or if you have a
naturally oily skin
• Hot and/or humid weather conditions
FemSeven® Conti must not be applied either on
or near the breasts. It is advisable to avoid applying
the patch to the same site twice running. At least
one week should be allowed to elapse between
applications to the same site.
Putting on the patch:
1. Remove the patch from its pouch as shown in
pictures 1 and 2.
2. Peel off half the protective liner at the S-shaped
notch and apply the patch to the skin as in
pictures 3 and 4.
Avoid touching the adhesive side of the patch
with your ﬁngers as this may prevent it sticking
properly later on.
3. Remove the other half of the protective liner then
press the patch against your skin with the palm of
your hand for at least 30 seconds shown in
pictures 5 and 6. The warmth of your body will
make the patch stick better.

4. POSSIBLE SIDE EFFECTS
The following diseases are reported more often in
women using HRT compared to women not using HRT:
• breast cancer;
• abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs
(venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT is started over the
age of 65.
For more information about these side effects, see
section 2.
Like all medicines, FemSeven® Conti can cause side
effects, although not everybody gets them.
Most of the effects observed with FemSeven® Conti
are weak to moderate and do not require the
treatment to be stopped.
Should the following persist, ask your doctor’s
advice, who may adapt the treatment: hot ﬂushes,
headaches, inconvenient vaginal dryness, nausea,
vomiting, abdominal pain, tightness in the breasts,
eye irritation from contact lenses, irritability, heavy
legs and weight gain.
In the case of heavy or irregular gynaecological
bleeding, consult your doctor.
The most frequent side effects may occur very
commonly (in more than 1 in 10 people):
• skin irritation at the site of application
(disappeared 2 or 3 days after patch removal);
• breast tenderness;
• bleeding or spotting.
The following side effects may occur commonly
(up to 1 in 10 people):
• breast pain (mastodynia);
• headache;
• indigestion (dyspepsia).
The following side effects may occur
uncommonly (up to 1 in 100 people):
• ﬂuid retention, swelling (oedema),
• weight increase/loss;
• fatigue;
• leg cramps;
• dizziness
• migraine;
• bloating;
• abdominal cramps;
• feeling sick (nausea);
• hypertension;
• excessive thickening of the womb lining
(endometrial hyperplasia);
• benign breast tissue changes;
• depression.
The following potential side effects may occur
rarely (up to 1 people in 1,000):
• presence of gallstones in the gallbladder
(cholelithiasis);
• yellowing of your skin or the whites of your eyes
(cholestatic jaundice);
• increase in size of ﬁbroids inside your womb
(uterine ﬁbrosis).
The following side effects have been reported
with other HRTs:
• gall bladder disease;
• various skin disorders:
• discoloration of the skin especially of the face or
neck known as “pregnancy patches” (chloasma);
• painful reddish nodules (erythema nodosum);
• rash with target-shaped reddening or sores
(erythema multiforme);
• vascular purpura (occasional reddening of the skin).

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaﬂet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE FEMSEVEN® CONTI
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date refers
to the last day of that month.
Do not store FemSeven® Conti above 30°C.
Keep your patches in the sachets they come in until
just before you need each one.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What FemSeven® Conti contains

120mm

It is possible to take a shower or have a bath without
removing the transdermal patch. In the event that
the transdermal patch should become detached
prematurely, i.e. before the seventh day (due to
vigorous physical activity, excessive sweating,
abnormal chaﬁng of clothing), a new patch should
be applied (to aid compliance it is recommended
that the patient then continues to change the patch
on the original scheduled day).
• Once applied, the transdermal patch has to be
covered by clothes to avoid direct exposure to
sunlight.
• Removal of the transdermal patch should be
carried out slowly to avoid irritating the skin.
In the event of some of the adhesive remaining on
the skin, this can usually be removed by gently
rubbing with a cream or an oily lotion.
• After use, FemSeven® Conti is to be folded in two
(with the adhesive surface to the inside) and
disposed of.

If you use more FemSeven® Conti than you
should
Overdose is unlikely but it can cause the following:
• breast tenderness;
• swelling of the abdomen/pelvis;
• anxiety;
• irritability;
• feeling sick (nausea);
• vomiting.
These symptoms will disappear gradually on removal
of the patches.
Should the signs persist, ask your doctor’s advice.

Detailed information on this medicine is available on
the web site of the Medicines and Healthcare
products Regulatory Agency (MHRA).

If you forget to change your patch of
FemSeven® Conti
Change your patch as soon as possible, then resume
your original schedule. Breakthrough bleeding is more
likely if you forget to change your patch on time.
Do not take a double dose to compensate for the
patch you forget to change.

H43659
Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0089037
Valid For 7 Days from

Version 4.3

Approved
Page 2 of 3

14-Mar-2016

10846-D

120mm

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.